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BFH772 1%

Phase 2

Erythemato-telangiectatic Rosacea | Small molecule | Dermatology |Novartis AG|Last Updated: Feb 21, 2021

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment36

FDA Designations

No designations recorded

Clinical trial landscape

BFH772 1% · 1 trial · 1 indication

Phase 2 1
NCT01449591Safety, Tolerability and Efficacy of BFH772 in Rosacea PatientsErythemato-telangiectatic Rosacea
COMPLETED36 Analytics
PHASE2COMPLETED
Safety, Tolerability and Efficacy of BFH772 in Rosacea Patients
Erythemato-telangiectatic RosaceaUnlock trial analytics

Study Endpoints

Primary Endpoints

To assess the effect of BFH772 treatment compared to vehicle on non-transient facial erythema using the Investigator's assessment of facial erythema score
12 weeks

Secondary Endpoints

To evaluate a patient's assessment of flushing frequency via patient reported episodes and facial redness via a patient reported score
12 weeks
To measure blood levels of BFH772 in patients
12 weeks
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
BFH772EXPERIMENTAL -
VehiclePLACEBO_COMPARATOR -
MetronidazoleACTIVE_COMPARATOR -

Interventions

NameTypeDescription
BFH772 1% ointmentDRUG -
Vehicle ointmentDRUG -
Noritate® 1% creamDRUG -
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Eligibility Criteria

Age Range18 Years to 65 Years
SexALL
Healthy VolunteersNo
Study Sites6

Inclusion Criteria: * Have persistent facial erythema on the cheeks of at least moderate severity. * Women must not be able to bear children Exclusion Criteria: * Have more than 12 inflammatory lesions on the face * Previous treatment of facial skin with lasers or electrocauterisation within 2 mo...

Countries:United States
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Frequently asked questions about BFH772 1%

What is BFH772 1% used for?

BFH772 1% is an investigational small molecule being studied for the treatment of erythemato-telangiectatic rosacea, a form of rosacea characterized by redness and visible blood vessels. It is applied topically at a 1% concentration. The drug is not approved and remains in clinical development.

Who makes BFH772 1%?

BFH772 1% is being developed by Novartis AG, a global pharmaceutical company traded on the New York Stock Exchange under the ticker symbol NVS. The company is conducting clinical research to evaluate the safety and efficacy of this topical treatment for erythemato-telangiectatic rosacea.

What phase is BFH772 1% in?

BFH772 1% is in Phase 2 clinical development. A Phase 2 trial has been completed, but the drug remains investigational and has not received FDA approval. Further studies would be needed to establish its safety and efficacy before any regulatory submission.

What clinical trials is BFH772 1% in?

BFH772 1% has been studied in one completed Phase 2 clinical trial, identified as NCT01449591. This randomized, double-blind, placebo-controlled study enrolled 36 participants with erythemato-telangiectatic rosacea in the United States. The trial evaluated the safety, tolerability, and efficacy of the treatment.

Is BFH772 1% FDA approved?

No, BFH772 1% is not FDA approved. It is an investigational drug currently in Phase 2 clinical development for erythemato-telangiectatic rosacea. The completed Phase 2 trial represents early-stage research, and the drug has not yet been submitted for regulatory approval.